Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008983
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARFONAD | TRIMETHAPHAN CAMSYLATE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/26/1954 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/06/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |